Comprehensive Analysis of Mitotane-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System
Authors' conclusion
This study provides preliminary safety data on the practical application of mitotane, confirming some known adverse reactions and revealing other potential risks. These findings provide critical safety information for clinicians prescribing mitotane for the treatment of adrenocortical cancer.
Study context
- Population
- Adverse event reports with mitotane as the primary suspected drug, FDA Adverse Event Reporting System database since 2004
- Participants
- 772 cases
- Outcome
- Mitotane-related adverse event signals
Methodological detailsreporting ratios, multi-item γ Poisson constrictors, proportional reporting ratios, Bayesian confidence propagation neural networks
- Reporting ratios
- Multi-item γ Poisson constrictors
- Proportional reporting ratios
- Bayesian confidence propagation neural networks
Main finding
As reported in the abstract
- Positive signals for label-listed reactions: nausea, diarrhea, vomiting, dizziness, loss of appetite, adrenal insufficiency
- Potential reactions not on label: fatigue, malignant tumor progression, ovarian cysts, chills, amnesia, Q-T interval prolongation on ECG
- 21 433 114 adverse event reports retrieved
Original publication
Comprehensive Analysis of Mitotane-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System. Endocr Pract. Published 19 November 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →